This study will use the licensed HPV vaccine, Gardasil, as a surrogate for an HIV vaccine, in order to explore some of the ethico-legal,psycho-social and logistical challenges involved in running an HIV vaccine trial in adolescents.

This study will use the licensed HPV vaccine, an alternative STI vaccine, as a proxy for an HIV vaccine and thereby identify potential challenges to the inclusion of adolescents in HIV prevention trials. The study will allow for site capacity building in terms of recruiting and retaining an HIV-negative high-risk adolescent cohort, and assessing the acceptability of an STI vaccine to adolescents and their parents or guardians. Correlates of vaccine uptake, refusal, retention and attrition will be determined. In addition, the study will document the incidence of HIV, other sexually transmitted infections (STI's) and pregnancies and circumcisions in this age group. Different methods of assessing understanding in adolescents will be tested, to ensure that informed consent is being achieved. Experiences of privacy and confidentiality issues for adolescents in such research will be explored. Finally, psycho-social correlates of sexual risk and protective behaviour will be examined.

The study is designed as a longitudinal cohort study with a self-selected intervention and control group. Adolescents and parents will be recruited through community outreach and invited to attend a Vaccine Discussion Group (VDG) to learn more about the HPV vaccine. Parental/ legal guardian consent and adolescent assent will be obtained prior to screening. After screening to ensure volunteers meet inclusion criteria, 1400 participants will be enrolled across seven sites. At this point, they will decide whether or not they want to receive the HPV vaccine. Those who do will receive three doses, at 0, 2 and 6 months. All participants will undergo HIV and pregnancy testing, receive risk reduction counseling and complete questionnaires at 0, 2, 6 and 9 months. Recruitment and retention will be monitored and data as described above will be collected throughout the course of the study.

Eligibility

Ages Eligible for Study:

12 Years to 17 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

South African adolescents aged 12 to 17

Criteria

Inclusion Criteria:

Youth age 12-17 years

For 12-15 year olds - no sexual risk criteria

For 16-17 year olds (the age of lawful consent to sex in South Africa): sexually active (ever had sexual intercourse)

Willing to participate in HIV testing and counseling

Willing and able to assent to study

Parent or legal guardian willing to provide written consent

HIV-negative serostatus at screening and enrolment

Females must have a negative pregnancy test at screening/enrolment

Females must not be breastfeeding

Additional inclusion criteria for those accepting HPV vaccination:

No HPV immunizations

Females should agree to avoid pregnancy through to the end of the study and to take contraceptives throughout the study (access provided)

Previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)

Current immunomodulator therapy

Receipt of immunosuppressor therapy (more than 10mg/day of prednisone or equivalent for >1 week) in the 6 months preceding enrollment date

Receipt of any vaccine within two weeks preceding enrollment date

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944879